Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability, 8756-8757 [E7-3259]

Download as PDF cprice-sewell on PROD1PC62 with NOTICES 8756 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices Outbreak,’’ P06–131, September 14, 2006, available at https://www.fda.gov/po/indexes/ 2006news.html. 4. U.S. Centers for Disease Control and Prevention, ‘‘Update on Multi-State Outbreak of E. coli O157:H7 Infections From Fresh Spinach, October 6, 2006, available at https:// www.cdc.gov/ecoli/2006/september/updates/ 100606.htm. 5. U.S. Department of Health and Human Services and U.S. Department of Agriculture, ‘‘Dietary Guidelines for Americans 2005,’’ January 2005, available at https:// www.healthierus.gov/dietaryguidelines/. 6. U.S. Food and Drug Administration, ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,’’ October 26, 1998, available at https:// www.cfsan.fda.gov/~dms/prodguid.html. 7. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods, ‘‘Letter to Firms that Grow, Pack, or Ship Fresh Lettuce and Fresh Tomatoes,’’ February 5, 2004, available at https:// www.cfsan.fda.gov/~dms/prodltr.html. 8. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods, ‘‘Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-cut Lettuce,’’ November 4, 2005, available at https://www.cfsan.fda.gov/~dms/ prodltr2.html. 9. U.S. Food and Drug Administration, ‘‘Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,’’ March 2006, available at https:// www.cfsan.fda.gov/~dms/prodgui2.html. 10. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, FDA Food Code, 2005, available at https://www.cfsan.fda.gov/~dms/ foodcode.html. 11. U.S. Food and Drug Administration, ‘‘Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated With Fresh Produce Consumption,’’ October 2004, available at https://www.cfsan.fda.gov/~dms/ prodpla2.html. 12. Produce Marketing Association and United Fresh Fruit and Vegetable Association, ‘‘Commodity Specific Food Safety Guidelines for the Melon Supply Chain,’’ November 7, 2005, available at https://www.cfsan.fda.gov/~dms/ melonsup.html or https://www.cfsan.fda.gov/ ~acrobat/melonsup.pdf. 13. International Fresh-Cut Produce Association, Produce Marketing Association, United Fresh Fruit and Vegetable Association, Western Growers Association; Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain; April 25, 2006, available at https:// www.cfsan.fda.gov/~dms/lettsup.html or https://www.cfsan.fda.gov/~acrobat/ lettsup.pdf. 14. North American Tomato Trade Work Group, ‘‘Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, May 2006, available at https:// www.cfsan.fda.gov/~dms/tomatsup.html or https://www.cfsan.fda.gov/~acrobat/ tomatsup.pdf. VerDate Aug<31>2005 15:22 Feb 26, 2007 Jkt 211001 Dated: February 21, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 07–891 Filed 2–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0480] Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.’’ In recent years, the practice of complementary and alternative medicine (CAM) has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act. DATES: Submit written or electronic comments on the draft guidance by April 30, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and Planning (HF–23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–0587. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.’’ The term ‘‘complementary and alternative medicine’’ (CAM) encompasses a wide array of health care practices, products, and therapies that are distinct from practices, products, and therapies used in ‘‘conventional’’ or ‘‘allopathic’’ medicine. In the United States, the practice of CAM has risen dramatically in recent years. In 1992, Congress established the Office of Unconventional Therapies, which later became the Office of Alternative Medicine (OAM), to explore ‘‘unconventional medical practices.’’ In 1998, OAM became the National Center for Complementary and Alternative Medicine (NCCAM). NCCAM is a center within the National Institutes of Health. The Institute of Medicine, in its book entitled, Complementary and Alternative Medicine in the United States, stated that more than one-third of American adults reported using some form of CAM and that visits to CAM providers each year exceed those to primary care physicians (see Institute of Medicine, Complementary and Alternative Medicine in the United States, pages 34 through 35 (2005)). As the practice of CAM has increased in the United States, we have seen increased confusion as to whether certain products used in CAM (which, for convenience, we will refer to as ‘‘CAM products’’) are subject to regulation under the act or the PHS Act. We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act. (When the draft guidance mentions a particular CAM therapy, practice, or product, it does so in order to provide background information or to serve as an example or illustration; any mention of a particular CAM therapy, practice, or product should not be construed as expressing FDA’s support for or endorsement of that particular CAM therapy, practice, or product or, unless specified otherwise, as an agency determination that a particular product E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices is safe and effective for its intended uses or is safe for use.) The draft guidance makes the following two fundamental points: • First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. • Second, neither the act nor the PHS Act exempts CAM products from regulation. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the regulation of complementary and alternative medicine products by FDA. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/ohrms/dockets/ default.htm. Dated: December 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–3259 Filed 2–26–07; 8:45 am] cprice-sewell on PROD1PC62 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 15:22 Feb 26, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0020] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Oxygen Pressure Regulators and Oxygen Conserving Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Christy Foreman, Center for Devices and Radiological Health (HFZ–340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240–276– 0120. SUPPLEMENTARY INFORMATION: I. Background Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.’’ The draft guidance document is intended to assist manufacturers in complying with minimum performance, testing, and labeling recommendations that are being proposed for these devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen into class II, subject to special controls. The proposal would also establish separate identification classifications for both oxygen pressure regulators and oxygen conserving devices, and would make those oxygen conserving devices that incorporate a built-in oxygen pressure regulator subject to special controls. This draft guidance is not final nor is it in effect at this time. DATES: Submit written or electronic comments on the draft guidance by May 29, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 1–800– 638–2041. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 101, Rockville, MD 20852. Submit SUMMARY: PO 00000 8757 Frm 00080 Fmt 4703 Sfmt 4703 This draft guidance provides FDA’s recommendations to manufacturers for labeling and for determining ignition sensitivity and fault tolerance for oxygen pressure regulators. These devices are intended to convert medical oxygen pressure from a high variable pressure to a lower, more constant working pressure. The device is affixed to a pressurized container of oxygen and the regulator controls the gas flow. These devices are currently regulated as class I devices. However, FDA has received reports of fires and explosions associated with the use of oxygen pressure regulators resulting in serious injury to a number of equipment operators, including one fatality. The draft guidance, if finalized, would serve as the special control for these devices. FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the Federal Food, Drug, and Cosmetic Act (the act), would address the risks associated with oxygen pressure regulators and provide reasonable assurance of their safety and effectiveness. The draft guidance would also serve as a special control for oxygen conserving devices with a built-in oxygen pressure regulator; a device type already classified into class II under the generic device type noncontinuous ventilator (21 CFR 868.5905). FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of oxygen conserving devices with a built-in oxygen pressure regulator. In the Federal Register of May 27, 2003 (68 FR 30214), FDA announced its intention to reclassify oxygen pressure regulators in its semi-annual regulatory agenda. FDA received one comment supporting the establishment of a proposed rule to reclassify these devices. E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Notices]
[Pages 8756-8757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3259]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0480]


Draft Guidance for Industry on Complementary and Alternative 
Medicine Products and Their Regulation by the Food and Drug 
Administration; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Complementary 
and Alternative Medicine Products and Their Regulation by the Food and 
Drug Administration.'' In recent years, the practice of complementary 
and alternative medicine (CAM) has increased in the United States, and 
we have seen increased confusion as to whether certain products used in 
CAM are subject to regulation under the Federal Food, Drug, and 
Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have 
also seen an increase in the number of CAM products imported into the 
United States. Therefore, the draft guidance discusses when a CAM 
product is subject to the act or the PHS Act.

DATES: Submit written or electronic comments on the draft guidance by 
April 30, 2007. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests. Submit written comments on the 
draft guidance to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and 
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0587.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Complementary and Alternative Medicine Products and Their 
Regulation by the Food and Drug Administration.'' The term 
``complementary and alternative medicine'' (CAM) encompasses a wide 
array of health care practices, products, and therapies that are 
distinct from practices, products, and therapies used in 
``conventional'' or ``allopathic'' medicine.
    In the United States, the practice of CAM has risen dramatically in 
recent years. In 1992, Congress established the Office of 
Unconventional Therapies, which later became the Office of Alternative 
Medicine (OAM), to explore ``unconventional medical practices.'' In 
1998, OAM became the National Center for Complementary and Alternative 
Medicine (NCCAM). NCCAM is a center within the National Institutes of 
Health. The Institute of Medicine, in its book entitled, Complementary 
and Alternative Medicine in the United States, stated that more than 
one-third of American adults reported using some form of CAM and that 
visits to CAM providers each year exceed those to primary care 
physicians (see Institute of Medicine, Complementary and Alternative 
Medicine in the United States, pages 34 through 35 (2005)).
    As the practice of CAM has increased in the United States, we have 
seen increased confusion as to whether certain products used in CAM 
(which, for convenience, we will refer to as ``CAM products'') are 
subject to regulation under the act or the PHS Act. We have also seen 
an increase in the number of CAM products imported into the United 
States. Therefore, the draft guidance discusses when a CAM product is 
subject to the act or the PHS Act. (When the draft guidance mentions a 
particular CAM therapy, practice, or product, it does so in order to 
provide background information or to serve as an example or 
illustration; any mention of a particular CAM therapy, practice, or 
product should not be construed as expressing FDA's support for or 
endorsement of that particular CAM therapy, practice, or product or, 
unless specified otherwise, as an agency determination that a 
particular product

[[Page 8757]]

is safe and effective for its intended uses or is safe for use.) The 
draft guidance makes the following two fundamental points:
     First, depending on the CAM therapy or practice, a product 
used in a CAM therapy or practice may be subject to regulation as a 
biological product, cosmetic, drug, device, or food (including food 
additives and dietary supplements) under the act or the PHS Act.
     Second, neither the act nor the PHS Act exempts CAM 
products from regulation.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
regulation of complementary and alternative medicine products by FDA. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3259 Filed 2-26-07; 8:45 am]
BILLING CODE 4160-01-S

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